Citizen Petitions

News & Analysis as of

FDA Denies Amgen’s Citizen’s Petition Awaiting Guidance from the Courts

As we have discussed before, the first generation of biosimilar litigation under the Biologics Price Control and Innovation Act (BPCIA) addresses whether the BPCIA’s patent dispute resolution procedures – the “patent dance” –...more

FDA Denies Amgen's Citizen Petition Regarding Biosimilar Applicant Requirements

Late last week, the U.S. Food and Drug Agency (FDA) dismissed a citizen petition filed by Amgen, Inc. asking the agency to require that biosimilar applicants provide the reference product sponsor with a copy of their...more

Denied Again: FDA Denies Amgen’s Citizen Petition Requesting Certification of Compliance with BPCIA Patent Dance

As discussed previously in Next Steps in the Dance: Amgen Files Citizen Petition at FDA Requesting Mandatory Compliance with BPCIA Patent Procedures, Amgen Inc. (“Amgen”) filed a Citizen Petition with the FDA requesting that...more

Citizen Petitions Aimed at Delaying Generic Competition Remain a Concern

Despite Congress enacting legislation in 2007 to curb misuse, citizen petitions submitted by pharmaceutical companies to the Food and Drug Administration (FDA) may still provide a mechanism for competitors to delay the...more

Petition Questions Lack Of MTA Regulations

Soon, the Office of Administrative Law will decide whether it will determine the merits of a petition for review of underground regulations allegedly being enforced by the Department of Business Oversight (fka Department of...more

Citizen Petitions To Ban Fracking Continue to Gain Momentum In Colorado

Two petitions were turned in to place before local voters ballot measures to ban fracking. On July 9, 2013, opponents of hydraulic fracturing turned in a petition seeking to ban hydraulic fracturing within the city limits of...more

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